RecruitingNot ApplicableNCT06244264

The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis

A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis


Sponsor

Guangdong Provincial People's Hospital

Enrollment

118 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. The main questions it aims to answer are: * Does autologous blood transfusion increase the incidence of new metastases? * Does autologous blood transfusion affect postoperative hemoglobin levels and the number of circulating tumor cells in the blood? * Can autologous blood transfusion reduce the rate of allogeneic transfusion during and after surgery for spinal metastases?


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a patient's own blood collected during surgery (autologous transfusion) is safe and effective compared to using donated blood in spinal surgery for lung cancer that has spread to the spine. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with lung cancer that has spread to the spine - Your expected survival is more than 3 months and you can tolerate surgery - You have an unstable spine and/or nerve compression that requires surgery - Your hemoglobin drops below 90 g/L during or after surgery, requiring a blood transfusion **You may NOT be eligible if...** - You have serious heart dysfunction or heart failure - You have a blood disorder or clotting problems - You have severe kidney disease requiring dialysis - You have a serious bloodstream infection (sepsis) - You or your family are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutoblood transfusion

Through a negative pressure suction device, the patient's blood that flows out during surgery is collected into a blood storage filter. During the suction process, it is mixed with an appropriate anticoagulant and passed through multiple layers of filters. When the volume of recovered blood reaches a certain level, it is continuously (or intermittently) centrifuged. Using a high-speed centrifugal blood recovery tank, the red blood cells are separated, and the plasma, waste, cell fragments, anticoagulants, and harmful components are diverted into a waste bag. A large amount of saline is used to repeatedly wash, purify, and concentrate the red blood cells. Finally, the concentrated red blood cells are prepared into a 70% red blood cell suspension with saline and stored in a collection bag for transfusion back to the patients. Open surgery is considered as the standard procedure for metastatic spinal cord compression


Locations(1)

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

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NCT06244264


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